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Checkpoint Inhibitor

Rogaratinib + Atezolizumab for Bladder Cancer (FORT-2 Trial)

Phase 1

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Ineligibility for cisplatin-based chemotherapy as defined by specified criteria

Existence of archival or fresh tumor biopsy specimen for FGFR1/3 mRNA expression testing

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 months

Awards & highlights

FORT-2 Trial Summary

This trial is designed to study the safety and efficacy of a combination of two drugs, rogaratinib and atezolizumab, in patients with untreated urothelial carcinoma who have a specific genetic change (FGFR-positive). The study was originally planned to have two parts, but the sponsor has decided to only conduct the first part, which is designed to determine the recommended dose of the combination (RP2D) as well as the safety and pharmacokinetics of the combination.

Who is the study for?

This trial is for adults with untreated FGFR-positive urothelial carcinoma, including bladder cancer. Participants need a high level of FGFR1/3 mRNA in tumor biopsies and no prior systemic treatment for advanced or metastatic cancer. Those who had local treatments must have finished them at least 4 weeks before the study starts.Check my eligibility

What is being tested?

The trial tests Rogaratinib combined with Atezolizumab to see if it's safe and effective against urothelial carcinoma. Phase 1b determines safety and dosage, while Phase 2 was planned to compare its effectiveness against a placebo but will not be conducted.See study design

What are the potential side effects?

Possible side effects include hearing loss, nerve issues like tingling sensations, heart problems such as unstable angina or recent heart attacks, retinal disorders, autoimmune diseases like lupus or rheumatoid arthritis, new-onset chest pain within the last three months.

FORT-2 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I cannot receive cisplatin-based chemotherapy due to certain health reasons.

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I have a tumor biopsy available for FGFR1/3 testing.

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My tumor has high levels of FGFR1 or 3 based on a biopsy test.

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My cancer is advanced or has spread and is in the bladder, kidney area, ureters, or urethra.

FORT-2 Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants with Dose-limiting toxicities(DLTs) in Part A

Number of participants with drug-related TEAEs in Part A

Number of participants with treatment-emergent adverse events (TEAEs) in Part A

+1 more

Secondary outcome measures

Area under the curve(0-8) (AUC(0-8)) of rogaratinib in Part A

Maximal plasma concentration (Cmax) of rogaratinib in Part A

Objective Response Rate(ORR) in Part A

FORT-2 Trial Design

1Treatment groups

Experimental Treatment

Group I: Rogaratinib + Atezolizumab in Part AExperimental Treatment2 Interventions

Part A: Part A is conducted in patients who are cisplatin-ineligible and have had no prior systemic treatment for locally advanced or metastatic disease. Patients will receive rogaratinib plus atezolizumab combination treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rogaratinib (BAY1163877)

2018

Completed Phase 3

~200

Atezolizumab

2017

Completed Phase 3

~5860

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

BayerLead Sponsor

2,240 Previous Clinical Trials

25,332,740 Total Patients Enrolled

Media Library

Atezolizumab (Checkpoint Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT03473756 — Phase 1

Bladder Cancer Research Study Groups: Rogaratinib + Atezolizumab in Part A

Bladder Cancer Clinical Trial 2023: Atezolizumab Highlights & Side Effects. Trial Name: NCT03473756 — Phase 1

Atezolizumab (Checkpoint Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03473756 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What therapeutic applications is Rogaratinib (BAY1163877) typically employed for?

"Rogaratinib (BAY1163877) is commonly used to treat small cell lung cancer, but it can also be employed in the management of neoplastic malignancies, non-small cell lung carcinoma, and postoperative conditions."

Answered by AI

Does Rogaratinib (BAY1163877) pose any risks to individuals participating in the trial?

"The safety of Rogaratinib (BAY1163877) was assessed by our team at Power and given a score of 1 as this is an early-stage trial, meaning there are limited data points to support its efficacy and security."

Answered by AI

Is this research project accepting new participants?

"At the moment, this research project is not taking on new participants. It was initially registered to clinicaltrials.gov in May of 2018 and last edited October 21st 2022. If you are searching for other studies, there are 2518 trials actively recruiting transitional cell carcinoma patients and another 353 seeking Rogaratinib (BAY1163877) test subjects."

Answered by AI

Is this scientific exploration unprecedented in its scope?

"Research for Rogaratinib (BAY1163877) commenced in 2008, when Hoffmann-La Roche sponsored a trial of 720 participants. This led to the drug receiving its Phase 2 approval, and presently 353 studies are underway across 74 nations and 1648 cities."

Answered by AI

What precedent has been set regarding Rogaratinib (BAY1163877) in the scientific literature?

"Rogaratinib (BAY1163877) was initially researched at SCRI Tennessee Oncology Chattanooga in 2008. At present, 18407 trials have been completed and 353 are currently taking place; many of these studies are conducted around Tucson, Arizona."

Answered by AI

To what extent has this trial been implemented across various sites?

"Currently, participants are being recruited from 5 different clinics, located in Tucson, New york and Chicago as well as other nearby cities. To facilitate enrolment, it is advisable to select the clinic closest to you that has an open spot."

Answered by AI

What is the capacity of participants in this experiment?

"This clinical trial has already concluded its recruitment drive, which began in May 2018 and ended on October 2021. Nonetheless, 2518 trials associated with transitional cell carcinoma are still underway and 353 studies concerned with the drug Rogaratinib (BAY1163877) remain open to participants."

Answered by AI

Recent research and studies

International Journal of CancerJournal

Rogaratinib: A Potent and Selective Pan‐fgfr Inhibitor with Broad Antitumor Activity in Fgfr‐overexpressing Preclinical Cancer Models

Grünewald, Sylvia, Oliver Politz, Sebastian Bender, Mélanie Héroult, Klemens Lustig, Uwe Thuss, Christoph Kneip, et al.. 2019. “Rogaratinib: A Potent and Selective Pan‐fgfr Inhibitor with Broad Antitumor Activity in Fgfr‐overexpressing Preclinical Cancer Models”. International Journal of Cancer. Wiley. doi:10.1002/ijc.32224.

International Journal of CancerJournal

Rogaratinib: A Potent and Selective Pan‐fgfr Inhibitor with Broad Antitumor Activity in Fgfr‐overexpressing Preclinical Cancer Models

clinicaltrials.govStudy

Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma

2018. "Phase 1b/2 Study of Rogaratinib (BAY1163877) in Combination With Atezolizumab in Urothelial Carcinoma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03473756.